Press release - 25 October 2010

BSI, a world class full-service Notified Body, announces its global launch of the Clinical Strategy Review for manufacturers applying for CE marking in order to place their medical device on the European market. The new service helps manufacturers ensure ahead of time that their clinical evaluation plan will be acceptable to meet the regulatory requirements needed by the Notified Body. BSI debuts this service at the 2010 Regulatory Affairs Professionals Society (RAPS) Annual Conference and Exhibition taking place October 24 – 27, in San Jose, California.

Recent revisions to the European regulations now place an even greater demand for thorough clinical evaluation as part of the technical documentation. Many companies find producing supporting data to be challenging, costly and very time-consuming. Nevertheless, the manufacturer is solely responsible to demonstrate valid clinical evidence of product safety and performance.

“Involving BSI sooner in the process, the manufacturer can gain a clearer understanding of what the Notified Body expects and feel more confident their data will be sufficient to meet the requirements,” states Paul Brooks, Vice President, BSI Healthcare.

“Ordinarily the manufacturer submits their clinical evaluation plan at the end of the product development process as part of the full CE marking technical document review,” explains Gert Bos, Head of Regulatory and Clinical Affairs, BSI Healthcare. “However, with our voluntary modular approach, BSI can perform the review much earlier in the process; after the plan has been finalized but prior to execution.” It should be noted the BSI Clinical Strategy Review is based on the manufacturer’s successful achievement of its clinical plan, the current legislation and related guidance used at the time of the review which can change by the completion of an investigation.

The highly trained BSI Team of Product Experts has extensive experience in both regulatory and industry, working with large international firms with diversified product portfolios to small start-ups with a single medical device. As a Notified Body they successfully balance the requirement to maintain objectivity and independence while providing practical feedback. Companies large or small, obtaining clinical strategy agreement with their Notified Body, will be seen in the market place as achieving a milestone on the pathway to Europe.

“Having the clinical plan reviewed prior to execution reduces risks of unexpected questions or surprises just prior to the planned launch,” said Ibim Tariah, Technical Director, BSI Healthcare. “If concerns are identified they can be addressed early and this places the company in a much better position to meet their time-to-market goals.”